CMC requires timely and sufficient funding throughout its research, process design, and drug development phase. They also need budgetary insights to plan manufacturing runs, acquire necessary equipment, and hire appropriate human resources. Usually, these are irreversible commitments made over a multiyear time horizon. Additionally, we see CMC estimate material requirements, secure vendor contracts, and evaluate in-house versus outsourcing of activities. When outsourcing, CMC must address unpredictability from CDMO or testing partners, outcomes from clinical studies, and changes to regulatory requirements. Given these uncertainties, the CMC plan is frequently revised, making it difficult to foretell the value and timing of expenditures.
Meanwhile, Finance requires periodic inputs from CMC to plan for and manage capital and operational investments. The uncertainties in CMC programs make it challenging for Finance to prepare short-term and long-term forecasts. Accurate forecasting is critical for Finance to secure sufficient capital investments. But the inability to raise funds when needed impacts CMC plans and timelines. This pushes CMC to make internal assessments, aligning with development partners and clinical teams on the downstream impacts of such changes. We find that CMC is not always equipped for analyzing such complexities to provide these assessments. In conversations with CMC and Finance clients, I have seen where differences in perspective and language between these functions are the root cause of issues.